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This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival (PFS) in participants with previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or modified infusional 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (mFOLFOX6) plus bevacizmab administered until first disease progression. Participants will then continue with Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second disease progression. The anticipated time on study treatment is 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab: Phase A and Phase B | Experimental | The trial will consist of 2 phases of treatment. Phase A: Participants will receive bevacizumab 7.5 mg/kg intravenous (IV) infusion on Day 1 every 3 weeks in combination with XELOX (capecitabine and oxaliplatin) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin, leucovorin, and 5-fluouracil) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants will continue receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluouracil) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment should commence within 4 weeks of the date of documented first disease progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | Participants will receive oxaliplatin 85 milligrams per square meter (mg/m^2) IV infusion on Day 1 of every 2 weeks cycle during alternative Phase A treatment or 130 mg/m^2 on Day 1 of every 3 weeks cycle during Phase A treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. PFS was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (carcinoembryonic antigen [CEA]) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between NLR (NLR less than or equal to [≤] 5 vs greater than [>] 5) and PFS was reported as hazard ratio. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A | PFS until first progression was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS. |
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Inclusion Criteria:
For resected primary tumor participants, and participants with primary tumor in situ:
Additional inclusion criteria for participants with primary tumor in situ:
Exclusion Criteria:
Resected primary tumor participants, and participants with primary tumor in situ:
Additional exclusion criteria for participants with primary tumor in situ:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia | ||
| Macarthur Cancer Therapy Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32142532 | Derived | Clarke SJ, Burge M, Feeney K, Gibbs P, Jones K, Marx G, Molloy MP, Price T, Reece WHH, Segelov E, Tebbutt NC. The prognostic role of inflammatory markers in patients with metastatic colorectal cancer treated with bevacizumab: A translational study [ASCENT]. PLoS One. 2020 Mar 6;15(3):e0229900. doi: 10.1371/journal.pone.0229900. eCollection 2020. | |
| 23497305 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab: Phase A and Phase B | The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg IV on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase A |
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| Capecitabine | Drug | Participants will receive capecitabine 1000 mg/m^2 per oral (PO) twice daily on Days 1-14 of 3 weeks cycle during Phase A treatment. |
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| Bevacizumab | Drug | Participants will receive 7.5 mg/kg IV infusion on Day 1 every 3 weeks (Phase A treatment) or 5 mg/kg IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B). |
|
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| Leucovorin | Drug | Participants will receive leucovorin 400 mg/m^2 IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B). Investigators may elect to chose low dose of leucovorin (either 20 mg/m^2 or 50 mg total dose). |
|
| 5-Fluouracil | Drug | Participants will receive 5-fluouracil loading dose of 400 mg/m^2 IV on Day 1 followed by 2400 mg/m^2 continuous IV infusion over 46 hours Day 1 (Alternative Phase A treatment and Phase B). |
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| Irinotecan | Drug | Participants will receive irinotecan 180 mg/m^2 IV on Day 1 every 2 weeks during Phase B treatment. |
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| Baseline up to first disease progression, death or end of study (up to 4 years) |
| PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B | PFS in Phase B (PFS-B) was defined as the time from the start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS. | From the start of Phase B treatment to disease progression, death or end of study (up to 4 years) |
| Time to Failure of Strategy (TFS): Overall | TFS was defined as time from the start of initial treatment to documentation of first disease progression without entering Phase B, or second disease progression having entered Phase B. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate TFS. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall | DDC was defined as PFS + PFS-B. In cases where a participant did not enter Phase B, then DDC was defined as PFS. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. PFS-B was time from start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate DDC. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Overall Survival (OS) From the Start of Treatment to Study Completion: Overall | OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. Kaplan-Meier methodology was used to estimate OS. | Baseline until death or end of study (up to 4 years) |
| Survival Beyond First Disease Progression: Overall | Survival beyond first progression was defined as the time from the date of first disease progression to death due to any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate survival beyond first disease progression. | Baseline until death or end of study (up to 4 years) |
| OS: Phase B | Overall Survival in Phase B was defined as the time from the start of treatment in Phase B to death due to any cause. Kaplan-Meier methodology was used to estimate OS. | From the start of Phase B treatment death or end of study (up to 4 years) |
| Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A | Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B | Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. | From the start of Phase B treatment to disease progression, death or end of study (up to 4 years) |
| Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall | Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Percentage of Participants Who Underwent Liver Resection: Overall | The results include percentage of participants who underwent potentially curative liver resection. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Association Between NLR (NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between NLR (NLR ≤ 5 vs > 5) and OS was reported as hazard ratio. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Association Between NLR Normalization (First NLR Post-Baseline ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio | NLR was calculated from laboratory values as ratio of Neutrophils to Lymphocytes. NLR normalization was assessed by adding first post-baseline measurement of NLR to the primary model. This is equivalent to testing whether first change in NLR is significantly associated with outcome. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of ≥1 new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.The association between NLR normalization (first NLR post-baseline ≤5 vs >5) and PFS was reported as hazard ratio. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. PFS was defined as time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between longitudinal NLR (longitudinal NLR ≤5 vs N>5) and PFS was reported as hazard ratio. | Baseline up to disease progression, death or end of study (up to 4 years) |
| Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between longitudinal NLR (longitudinal NLR ≤5 vs NLR >5) and OS was reported as hazard ratio. | Baseline up to death or end of study (up to 4 years) |
| European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A | EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is "today" and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life. | Baseline, every 8-9 weeks thereafter, end of treatment (EOT) (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| EuroQol-5D Utility Score: Phase B | EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is "today" and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life. | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A | AQoL-8D provides a global utility score and comprised of 35 questions from which 8 dimensions (Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses) are derived. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| AQoL-8D Global Utility Score: Phase B | AQoL-8D provides a global utility score and consists of 8 separately scored dimensions including Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A | FACT-C is one part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL. | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| FACT-C Score: Phase B | FACT-C is one part of the FACIT Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL. | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| Campbelltown |
| New South Wales |
| 2560 |
| Australia |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| St Vincent'S Hospital; Clinical Oncology | Darlinghurst | New South Wales | 2010 | Australia |
| Mid North Coast Cancer Institute | Port Macquarie | New South Wales | 2444 | Australia |
| Royal North Shore Hospital; Department of Medical Oncology | St Leonards | New South Wales | 2065 | Australia |
| Sydney Adventist Hospital; Clinical Trial Unit | Sydney | New South Wales | 2076 | Australia |
| Royal Brisbane Hospital | Brisbane | Queensland | 4029 | Australia |
| Rockhampton Hospital | Rockhampton | Queensland | 4700 | Australia |
| The Townsville Hospital; Townsville Cancer Centre | Townsville | Queensland | 4812 | Australia |
| Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit | Elizabeth Vale | South Australia | 5112 | Australia |
| Calvary North Adelaide; North Adeliade Oncology Centre | North Adelaide | South Australia | 5006 | Australia |
| Launceston General Hospital | Launceston | Tasmania | 7250 | Australia |
| Austin Hospital; Medical Oncology | Heidelberg | Victoria | 3084 | Australia |
| Sunshine Hospital; Oncology Research | St Albans | Victoria | Australia |
| St John of God Murdoch Hospital; Oncology West | Murdoch | Western Australia | 6150 | Australia |
| St John of God Hospital; Bendat Cancer Centre | Subiaco | Western Australia | 6008 | Australia |
| Clarke S, Burge M, Cordwell C, Gibbs P, Reece W, Tebbutt N. An Australian translational study to evaluate the prognostic role of inflammatory markers in patients with metastatic ColorEctal caNcer Treated with bevacizumab (Avastin) [ASCENT]. BMC Cancer. 2013 Mar 15;13:120. doi: 10.1186/1471-2407-13-120. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase B |
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Full Analysis Set (FAS) included all participants who received at least 1 dose of bevacizumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab: Phase A and Phase B | The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. PFS was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (carcinoembryonic antigen [CEA]) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between NLR (NLR less than or equal to [≤] 5 vs greater than [>] 5) and PFS was reported as hazard ratio. | FAS population. "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | hazard ratio | Baseline up to disease progression, death or end of study (up to 4 years) |
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| Secondary | PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A | PFS until first progression was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS. | FAS population. | Posted | Median | 95% Confidence Interval | months | Baseline up to first disease progression, death or end of study (up to 4 years) |
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| Secondary | PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B | PFS in Phase B (PFS-B) was defined as the time from the start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS. | Phase B FAS population included participants who received at least 1 dose of bevacizumab in Phase B. | Posted | Median | 95% Confidence Interval | months | From the start of Phase B treatment to disease progression, death or end of study (up to 4 years) |
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| Secondary | Time to Failure of Strategy (TFS): Overall | TFS was defined as time from the start of initial treatment to documentation of first disease progression without entering Phase B, or second disease progression having entered Phase B. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate TFS. | FAS population. | Posted | Median | 95% Confidence Interval | months | Baseline up to disease progression, death or end of study (up to 4 years) |
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| Secondary | Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall | DDC was defined as PFS + PFS-B. In cases where a participant did not enter Phase B, then DDC was defined as PFS. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. PFS-B was time from start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate DDC. | FAS population. | Posted | Median | 95% Confidence Interval | months | Baseline up to disease progression, death or end of study (up to 4 years) |
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| Secondary | Overall Survival (OS) From the Start of Treatment to Study Completion: Overall | OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. Kaplan-Meier methodology was used to estimate OS. | FAS population. | Posted | Median | 95% Confidence Interval | months | Baseline until death or end of study (up to 4 years) |
|
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| Secondary | Survival Beyond First Disease Progression: Overall | Survival beyond first progression was defined as the time from the date of first disease progression to death due to any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate survival beyond first disease progression. | FAS population. "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. | Posted | Median | 95% Confidence Interval | months | Baseline until death or end of study (up to 4 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS: Phase B | Overall Survival in Phase B was defined as the time from the start of treatment in Phase B to death due to any cause. Kaplan-Meier methodology was used to estimate OS. | Phase B FAS population. | Posted | Median | 95% Confidence Interval | months | From the start of Phase B treatment death or end of study (up to 4 years) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A | Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. | FAS population. | Posted | Number | percentage of participants | Baseline up to disease progression, death or end of study (up to 4 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B | Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. | Phase B FAS population. | Posted | Number | percentage of participants | From the start of Phase B treatment to disease progression, death or end of study (up to 4 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall | Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment. | FAS population. | Posted | Number | percentage of participants | Baseline up to disease progression, death or end of study (up to 4 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Underwent Liver Resection: Overall | The results include percentage of participants who underwent potentially curative liver resection. | FAS population. | Posted | Number | percentage of participants | Baseline up to disease progression, death or end of study (up to 4 years) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Association Between NLR (NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between NLR (NLR ≤ 5 vs > 5) and OS was reported as hazard ratio. | FAS population. "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | hazard ratio | Baseline up to disease progression, death or end of study (up to 4 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Association Between NLR Normalization (First NLR Post-Baseline ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio | NLR was calculated from laboratory values as ratio of Neutrophils to Lymphocytes. NLR normalization was assessed by adding first post-baseline measurement of NLR to the primary model. This is equivalent to testing whether first change in NLR is significantly associated with outcome. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of ≥1 new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.The association between NLR normalization (first NLR post-baseline ≤5 vs >5) and PFS was reported as hazard ratio. | FAS population. "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | hazard ratio | Baseline up to disease progression, death or end of study (up to 4 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. PFS was defined as time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between longitudinal NLR (longitudinal NLR ≤5 vs N>5) and PFS was reported as hazard ratio. | FAS population. "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | hazard ratio | Baseline up to disease progression, death or end of study (up to 4 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio | NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between longitudinal NLR (longitudinal NLR ≤5 vs NLR >5) and OS was reported as hazard ratio. | FAS population. "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome. | Posted | Number | 95% Confidence Interval | hazard ratio | Baseline up to death or end of study (up to 4 years) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A | EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is "today" and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life. | FAS population. "Number Analyzed" = participants who were evaluable at the specified time point for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, every 8-9 weeks thereafter, end of treatment (EOT) (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EuroQol-5D Utility Score: Phase B | EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is "today" and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life. | Phase B FAS population. "Number Analyzed" = participants who were evaluable at the specified time point for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A | AQoL-8D provides a global utility score and comprised of 35 questions from which 8 dimensions (Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses) are derived. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). | FAS population. "Number Analyzed" = participants who were evaluable at the specified time point for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AQoL-8D Global Utility Score: Phase B | AQoL-8D provides a global utility score and consists of 8 separately scored dimensions including Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health). | Phase B FAS population. "Number Analyzed" = participants who were evaluable at the specified time point for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A | FACT-C is one part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL. | FAS population. "Number Analyzed" = participants who were evaluable at the specified time point for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FACT-C Score: Phase B | FACT-C is one part of the FACIT Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL. | Phase B FAS population. "Number Analyzed" = participants who were evaluable at the specified time point for this outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles] |
|
Baseline up to end of study (up to 4 years)
FAS population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab: Phase A and Phase B | The trial consisted of 2 phases of treatment. Phase A: Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 every 3 weeks in combination with XELOX (oral capecitabine 1000 mg/m^2 twice daily Days 1-14, oxaliplatin 130 mg/m^2 IV Day 1) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85 mg/m^2 IV Day 1, leucovorin 400 mg/m^2 IV Day 1, 5-fluouracil 400 mg/m^2 IV loading dose then 2400 mg/m^2 continuous IV infusion over 46 hours Day 1) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants continued receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan 180 mg/m^2 IV Day 1, leucovorin and 5-fluouracil [same regimen as of mFOLFOX6]) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment had to commence within 4 weeks of the date of documented first disease progression. | 86 | 128 | 128 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Extravasation | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Eyelid infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000068258 | Bevacizumab |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
Not provided
Not provided
| Physician Decision |
|
| Other |
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